(305 days)
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.
The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
The provided text does not contain detailed acceptance criteria or a comprehensive study description with all the requested information for the SafeCT device. It mentions "performance testing" and "demonstrates the device safety and effectiveness" but lacks specifics on the acceptance criteria metrics, sample sizes, and expert involvement.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions that the device's performance was "validated by comparing the image quality of phantom and clinical processed data to the image quality of the original (unprocessed) corresponding data." The stated intended use is "enhancement of CT images by reduction of the image noise." While specific quantitative acceptance criteria are not provided, the implied criteria would be a perceptible and beneficial reduction in image noise without compromising diagnostic information. The reported device performance is that it "demonstrates the device safety and effectiveness" in achieving this.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Perceptible reduction in image noise in CT images. | Validated through comparison of processed vs. unprocessed phantom and clinical data. Effects are safe and effective. |
| Preservation of diagnostic information (no loss of detail due to noise reduction). | Implied by "assisting professional radiologists and specialists in reaching their own diagnosis." |
| Device processing is not effective for lesions, mass, or abnormalities of sizes less than 3 mm (limitation). | Stated as a limitation in the Indications for Use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document refers to "phantom and clinical processed data" but does not specify the number of cases or images in the test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, beyond the general statement of "assisting professional radiologists and specialists."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- The document does not explicitly state that an MRMC comparative effectiveness study was done. It only states that the device is "specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis." There is no mention of an effect size for human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document does not explicitly state whether a standalone performance study was done. The focus is on the device "assisting professional radiologists," implying a human-in-the-loop scenario.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth is implicitly based on "image quality" as perceived by "professional radiologists and specialists." This suggests a form of expert assessment or consensus on the quality of image enhancement (noise reduction and preservation of detail). There is no mention of pathology or outcomes data being used for ground truth.
8. The sample size for the training set
- The document does not provide any information regarding the training set or its sample size.
9. How the ground truth for the training set was established
- Since no information about a training set is provided, how its ground truth was established is also not available.
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b)
Device Name Proprietary Device Name: SafeCT
Establishment Name and Registration Number of Submitter
Name: Medic Vision Brain Technologies Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
DEC 1 4 2010
<100372
Device Classification
LLZ Product Code: 892.2050 CFR section: Panel Identification: Radiology Device Description: Picture archiving and communications system / Classification: Class II Product
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Predicate Device
K024028 SharpView, manufactured by ContextVision
Device Description
The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
Intended use and Indications for Use
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparing the image quality of phantom and clinical processed data to the image quality of the original (unprocessed) corresponding data. The results of the performance testing demonstrate the device safety and effectiveness.
Substantial Equivalency
It is Medic Vision opinion that the SafeCT is substantially equivalent in terms of safety and effectiveness to the predicate device.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Medic Vision Imaging Solutions, Ltd. % John J. Smith. M.D., J.D. Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street. NW WASHINGTON DC 20004
DEC 1 4 2010
Re: K100372
Trade/Device Name: SafeCT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2010 Received: November 19, 2010
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket, notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
DEC 1 4 2010
510(k) Number (if known):
Device Name: SafeCT
Indications for Use:
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Radiological Office of In Vitro Diagnostic Device Evalua
510K K100372
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).